Trial record 23 of 139 for:    sodium fluoride

Randomized Trial on Resin Infiltration in Deciduous Teeth (infiltration)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Turska Szybka, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01881100
First received: June 16, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.


Condition Intervention
White Spot Lesions
Caries
Other: resin infiltration
Other: fluoride varnish

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The condition of treated white spot lesions (WSL) were scored using the Nyvad et al. system (17): I-WSL (Inactive WSL) - inactive spot lesion, when surface was becoming smooth, hard and glossy; S -WSL (Sound WSL) - invisible spot lesion taking the appearance of healthy enamel with proper translucency level and surface texture. Active enamel lesions and assessment scores 3-6 according to ICDAS II within a year were considered as decayed (D-Enamel/Dental cavity). Treatment was considered successful when lesions did not progress (I-WSL or S-WSL); unsuccessful when lesions remained active and enamel underwent erosion - i.e. caries occurred (D).


Enrollment: 81
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resin infiltration
The test group (41 children) had caries lesions treated with the infiltration technique using Icon (DMG, Hamburg, Germany) and fluoride varnish (Duraphat, Colgate Palmolive, Hamburg, Germany)at baseline evaluation. Fluoride varnish was applied every control visit every three months during 1 year.
Other: resin infiltration
The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.
Other Names:
  • Icon DMG Germany
  • Duraphat Colgate Palmolive Germany
Other: fluoride varnish
All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).
Other Name: Duraphat Colgate Palmolive, Hamburg, Germany
Active Comparator: fluoride varnish
The control group (40 children) had all tooth surfaces including WSL treated with fluoride varnish (Duraphat Colgate Palmolive, Hamburg, Germany)only at baseline evaluation and every control visit every three months during 1 year.
Other: fluoride varnish
All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).
Other Name: Duraphat Colgate Palmolive, Hamburg, Germany

Detailed Description:
  • To determine the number of patients, sample size was based on data from studies assessing fluoride varnish efficacy in children with deciduous teeth (progression of caries reduction by 33 %)(95% CI, from 19 to 48%, P<0.0001); (α = 0.05; power = 80%; chi-square test2). The calculated sample size was 60 children and 120 white spot lesions. The initially planned number of participants was increased by expected 20% drop-out after 1 year, at least 72 children; the minimal number of treated active caries lesions amounted to 144.
  • Participants were allocated to the "test" and to the "control" group, respectively, by computer-generated randomly permuted blocks using package blockrand in R statistical software, sealed in envelopes.
  • The children were re-examined clinically by the same 2 examiners as at baseline evaluation.
  • Statistical analyses were performed using statistical software STATISTICA 10 (StatSoft), the level of significance was set at 0.05. Intra-examiner reliability was assessed by kappa statistics.
  • To compare average values between two independent groups U Mann-Whitney test was used (for e.g. to compare experimental group with the control one); Wilcoxon signed-rank test was used for paired samples (for e.g. to compare first measurement with final measurement for experimental group). Comparison of fractions was conducted using Pearson's chi-square test of independence and Z test. The 95% confidence intervals were calculated on the basis of normal approximation.
  Eligibility

Ages Eligible for Study:   18 Months to 71 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2)
  • a written consent of parents/ guardians for participation in the research study

Exclusion Criteria:

  • age above 5.9 years
  • systematic disease
  • cavitated lesions
  • enamel defects
  • current participation in another study
  • a planned change of residence within one year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881100

Locations
Poland
Dorota Olczak-Kowalczyk
Warsaw, Warsaw, 18 Miodowa St, Poland, 00-246
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Study Director: Dorota Olczak-Kowalczyk, Ass. Prof. Warsaw Medical University, 61 Żwirki i Wigury St.,02-091Warsaw
Study Director: Dorota Olczak-Kowalczyk, Ass.Prof. Warsaw Medical University, Poland
  More Information

No publications provided

Responsible Party: Anna Turska Szybka, Phd,MD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01881100     History of Changes
Other Study ID Numbers: No sponsor ID, WarsawMU
Study First Received: June 16, 2013
Last Updated: June 16, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
resin infiltration
randomized clinical trial
fluoride varnish
caries lesion
deciduous teeth

Additional relevant MeSH terms:
Fluorides, Topical
Fluorides
Sodium Fluoride
Sodium fluoride topical preparation
Listerine
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014